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    EudraCT Number:2020-003143-28
    Sponsor's Protocol Code Number:BB-2293-101b
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2022-06-01
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedNetherlands - Competent Authority
    A.2EudraCT number2020-003143-28
    A.3Full title of the trial
    First-in-Human, Double-Blind, Randomised, Vehicle-Controlled Phase I/II Proof of Concept Study to Investigate the Safety, Tolerability, Pharmacokinetics and Efficacy of BEN2293 in Patients with Mild to Moderate Atopic Dermatitis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of BEN2293 in Patients with Mild to Moderate Atopic Dermatitis
    A.4.1Sponsor's protocol code numberBB-2293-101b
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorBenevolentAI Bio Limited
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportBenevolentAI Bio Limited
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBenevolentAI Bio Limited
    B.5.2Functional name of contact pointAdepeju Oshisanya
    B.5.3 Address:
    B.5.3.1Street Address4-8 Maple Street
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeW1T 5HD
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+44718649883
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameBEN2293
    D.3.2Product code BEN2293
    D.3.4Pharmaceutical form Ointment
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPTopical
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot applicable
    D.3.9.1CAS number Not applicab
    D.3.9.2Current sponsor codeBB-2293-101b
    D.3.9.3Other descriptive nameBEN2293
    D.3.9.4EV Substance CodeSUB216479
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/W) percent weight/weight
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.0
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboOintment
    D.8.4Route of administration of the placeboTopical
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Atopic dermatitis
    E.1.1.1Medical condition in easily understood language
    Atopic dermatitis
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10003639
    E.1.2Term Atopic dermatitis
    E.1.2System Organ Class 100000004858
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to assess the safety and tolerability of BEN2293, administered as multiple topical doses to increasing body surface area (BSA), in patients with mild to moderate AD.
    E.2.2Secondary objectives of the trial
    · To investigate the plasma PK of BEN2293 and metabolite BEN6403 following multiple topical doses to mild to moderate AD patients.
    · To investigate the effect of BEN2293 on pruritus in patients with mild to moderate AD.
    · To investigate the effect of BEN2293 on AD in patients with mild to moderate AD.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Males and females with mild to moderate AD (based on vIGA) free from other clinically significant illness or disease that may adversely affect the safety of the patient or the integrity of the study as determined by medical history, physical examination, safety laboratory and other assessments.
    2. Willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.
    3. Patient is aged between 18 to 65 years, inclusive.
    4. Patient has a body mass index (BMI) of 18.0 to 35.0 kg/m2, inclusive.
    5. Body weight of ≥50 kg.
    6. History of AD for at least 6 months diagnosed by a dermatologist or GP.
    7. Previous or current successful treatment with topical corticosteroids.
    8. A vIGA score of 2 (mild) to 3 (moderate) at both Screening and Day -1 (Part A) and at Screening, Day -3 and Day 1 (Part B).
    9. Atopic dermatitis affecting between ≥1% to ≤30% BSA of treatable skin (not including face, scalp, genital area, palms of hands or soles of feet) at Screening and Day -1 for all cohorts in Part A and at Screening, Day -3 and Day 1 for Part B.
    10. History of AD associated pruritus with an itch score (NRS) of ≥4.
    · For Part A, the mean of the pruritus NRS scores (worst itch over the last 24 hours) obtained on Day -3, Day -2 and Day -1 during the emollient only washout phase will be used to assess inclusion.
    · For Part B, the mean of the pruritus NRS scores (worst itch over the last 24 hours) obtained on Day -5, Day -4 and Day -3 (pre-dose) during the emollient only washout phase, and the mean of these scores on each day of the run-in phase (Day -2, Day -1 and Day 1 [pre-dose]) will be used to assess inclusion at Day -3 and Day 1, respectively. Where the run-in phase is extended by 1 day, the mean NRS for all NRS scores reported over that time (minimum of 3) will be used to determine eligibility. Where patients are unable to provide 3 consecutive days of NRS scores for calculation of the average score to determine eligibility, a minimum of 3 scores taken over a maximum of 4 days will be used to calculate the average.
    11. Patients must be willing to stop applying their daily emollients and instead use the study emollient and shower cream from at least 7 days prior to Day 1 in Part A and 10 days prior to Day 1 in Part B, and throughout their participation in the study.
    12. Males must use a condom during the trial and for 3 months after their final dose study medication. In addition, their female partner of child-bearing potential must be established on an additional method of highly effective contraception (see Section 6.3.1) prior to dosing until 3 months following final dosing.
    13. Female patients of child-bearing potential must be established on a highly effective method of contraception prior to dosing until 3 months after last dose (see Section
    6.3.1 for highly effective method of contraception) in combination with male partner’s use of a condom during the trial and for 3 months after the last dose.
    14. Female patients must have a negative pregnancy test at Screening and Day -1 (Part A only) and at Screening, Day -3 and Day 1 (Part B only).
    15. Participant has a minimum of one AD area in a site suitable for biopsy.
    16. Written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
    E.4Principal exclusion criteria
    1. Atopic dermatitis of such severity that the patient could not comply with the demands of the study and/or the patient is not a suitable candidate for a placebo-controlled study, as per Investigator’s discretion.
    2. Any skin tattoo, scar, cuts, bruises, or other skin damage, including excessive UV exposure, at the possible IMP application sites.
    3. Patients who have AD lesions affecting >3% untreatable areas (face, scalp, genitals, palms of hands or soles of feet) (Cohorts 3 and 4 in Part A and Part B only).
    4. Patients who have a source of itch solely or significantly from untreatable areas (face, scalp, genitals, palms of hands or soles of feet) (Cohorts 3 and 4 in Part A and Part B only).
    5. Have concomitant skin disease or infection (e.g., acne, impetigo) or presence of skin comorbidities in the study area to be dosed that may interfere with study assessments.
    6. Patients who are excessively hirsute in areas of skin to be dosed with study ointment.
    7. Patients who are unwilling to stop hair removal by any means (including shaving, waxing or depilatory creams) to skin areas to be dosed with study ointment for 2 weeks prior to Day -1 and throughout the duration of the study.
    8. History of drug and/or alcohol abuse within the last 2 years, or intake of >21 units of alcohol weekly, or a positive alcohol breath test at Screening or Day -1 (Part A) and at Screening, Day -3 or Day 1 (Part B). One unit is equivalent to a 285 mL glass of full-strength beer or one (30 mL) measure of spirits or one small glass (100 mL) of wine.
    9. Regular use of tobacco and/or nicotine containing products within 3 months of Day 1, until the end of the study. Social smokers may be included in the study as long as they are able to abstain from smoking/vaping during residential stays (Part A only). Patients with a positive urine cotinine test at Screening or Day -1 will not be eligible (Part A only). Use of tobacco and/or nicotine containing products (up to 20 cigarettes per day, or equivalent) is permitted for patients in Part B.
    10. Clinically relevant history of abnormal physical or mental health interfering with the study as determined by medical history and physical examinations as judged by the Investigator (including [but not limited to], neurological, psychiatric, endocrine, cardiovascular, gastrointestinal, hepatic, or renal disorder).
    11. Positive urine test for drugs of abuse at Screening or Day -1 (Part A) and at Screening or Day -3 (Part B).
    12. Positive test for hepatitis B surface antigen (HBsAg), anti-hepatitis C antibody (anti-HCV), human immunodeficiency virus I and II (anti-HIV I/II) or SARS-CoV-2 at Screening.
    13. Clinically relevant abnormal laboratory results (including hepatic and renal panels, complete blood count, chemistry panel and urinalysis), 12-lead ECG and vital signs, or physical findings at Screening or Day -1 (Part A) and at Screening or Day -3 (Part B). In case of uncertain or questionable results, tests performed during Screening, Day -1 or Day -3 may be repeated once to confirm eligibility or judged to be clinically irrelevant.
    14. Part B only: Patients treated within 28 days of Day 1 with tricyclic antidepressants (e.g., amitriptyline), anticonvulsants (e.g., carbamazepine, gabapentin) or similar drugs that may interfere with itch sensation.
    15. Any other concomitant disease or condition that could interfere with, or for which the treatment might interfere with, the conduct of the study as outlined in this Protocol, or that would, in the opinion of the Investigator, pose an unacceptable risk to the patient in this study. Patients with asthma and hay fever can be included provided they are stable and not receiving oral steroids or antihistamines. Patients with conditions that have been stable for at least 3 months may be included, subject to the requirements above. Patients who have previously tested positive for SARS-CoV-2 virus will not be excluded, as long as they do not test positive at Screening and are COVID-19 symptom free.
    E.5 End points
    E.5.1Primary end point(s)
    Primary safety endpoints:
    · Adverse events, local tolerance assessments, vital signs, 12-lead ECG, laboratory safety tests (clinical chemistry, haematology and urinalysis).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Will be evaluated at the various timepoints
    E.5.2Secondary end point(s)
    Secondary PK endpoints:
    · Plasma concentration-time profiles and PK parameters for BEN2293 and BEN6403 including maximum observed plasma concentration (Cmax), time corresponding to the maximum observed plasma concentration (tmax), apparent terminal half-life (t1/2), area under the plasma concentration vs. time curve (AUC) over a dosing interval (AUCĪ„) (Part A only).
    · Accumulation ratio (Part A only).
    Secondary efficacy endpoints:
    · Time to itch reduction.
    · Fraction of patients achieving itch reduction.
    · Change from baseline in the Numerical Rating Score (NRS) for Pruritus (Worst Itch over 24 hours).
    · Change from baseline in the NRS for Pruritus (Current Itch).
    · Change from baseline in the Eczema Area and Severity Index (EASI) score.
    · Number of patients achieving improvement in EASI score.
    · Change from baseline in BSA affected by AD in treated area(s).
    · Change from baseline in validated Investigators Global Assessment (vIGA) Score.
    · Change from baseline in Patient Oriented Eczema Measure (POEM).
    · Change from baseline in Dermatology Life Quality Index (DLQI).
    · Change from baseline in EQ-5D.
    · Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS).
    · Change from baseline in Insomnia Severity Index ([ISI] for Part A, Cohorts 3 and 4 and Part B only).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Will be evaluated at the various timepoints
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability of BEN2293
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans Yes
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E. trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E. trial design description
    Adaptive design
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned13
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA13
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The end-of-study is defined as completion of the clinical activities relating to the Follow-up visit by the last patient.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months3
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 200
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 80
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state120
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 120
    F.4.2.2In the whole clinical trial 280
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Not Applicable
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Suvoda LLC
    G.4.3.4Network Country Spain
    G.4 Investigator Network to be involved in the Trial: 2
    G.4.1Name of Organisation ThermoFisher
    G.4.3.4Network Country United Kingdom
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2022-06-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-07-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-01-26
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